Adhesive ostomy base plate having a sensor assembly adapted to monitor a condition of the adhesive

ABSTRACT

An ostomy base plate includes an adhesive layer, a top layer, and a sensor assembly. The adhesive layer is adapted to adhere the ostomy base plate to skin of a user. The top layer is on a distal side of the ostomy base plate and has a top layer opening. The sensor assembly is disposed between the adhesive layer and the top layer and includes electrodes with electrical connection parts. The electrical connection parts of the electrodes extend through the top layer opening for electrical connection with a removable data monitor. The sensor assembly is adapted to monitor a state of condition of the adhesive layer.

The present disclosure relates to an ostomy system, devices thereof,method of manufacturing and method for monitoring an ostomy appliance.The ostomy appliance system comprises an ostomy appliance and an ostomymonitor device. In particular, the present disclosure relates to leakageclassification and/or detection and monitoring of the operation of anostomy appliance.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate and/or a sensorassembly part,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8 ,

FIG. 10 is a distal view of a part of the base plate and/or sensorassembly part including monitor interface,

FIG. 11 illustrates an exploded view of an exemplary base plate,

FIG. 12 illustrates an exploded view of an exemplary electrode assembly,

FIG. 13 illustrates an exploded view of an exemplary electrode assembly,

FIG. 14 shows an exemplary electrode configuration,

FIG. 15 shows a schematic representation of part of a base plate and/ora sensor assembly part,

FIG. 16 shows a schematic representation of part of a base plate and/ora sensor assembly part,

FIG. 17 shows a schematic representation of part of a base plate and/ora sensor assembly part, and

FIG. 18 shows a flowchart of an exemplary method.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter,with reference to the figures when relevant. It should be noted that thefigures may or may not be drawn to scale and that elements of similarstructures or functions are represented by like reference numeralsthroughout the figures. It should also be noted that the figures areonly intended to facilitate the description of the embodiments. They arenot intended as an exhaustive description of the invention or as alimitation on the scope of the invention. In addition, an illustratedembodiment needs not have all the aspects or advantages shown. An aspector an advantage described in conjunction with a particular embodiment isnot necessarily limited to that embodiment and can be practiced in anyother embodiments even if not so illustrated, or if not so explicitlydescribed.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably. Asubject having undergone ostomy surgery may be referred to as “ostomist”or “ostomate”—moreover, also as “patient” or “user”. However, in somecases “user” may also relate or refer to a health care professional(HCP), such as a surgeon or an ostomy care nurse or others. In thosecases, it will either be explicitly stated, or be implicit from thecontext that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of alayer, an element, a device or part of a device, the referral is to theskin-facing side or surface, when a user wears the ostomy appliance.Likewise, whenever referring to the distal side or surface of a layer,an element, a device or part of a device, the referral is to the side orsurface facing away from the skin, when a user wears the ostomyappliance. In other words, the proximal side or surface is the side orsurface closest to the user, when the appliance is fitted on a user andthe distal side is the opposite side or surface—the side or surfacefurthest away from the user in use.

The axial direction is defined as the direction of the stoma, when auser wears the appliance. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

The radial direction is defined as perpendicular to the axial direction.In some sentences, the words “inner” and “outer” may be used. Thesequalifiers should generally be perceived with respect to the radialdirection, such that a reference to an “outer” element means that theelement is farther away from a centre portion of the ostomy appliancethan an element referenced as “inner”. In addition, “innermost” shouldbe interpreted as the portion of a component forming a centre of thecomponent and/or being adjacent to the centre of the component. Inanalogy, “outermost” should be interpreted as a portion of a componentforming an outer edge or outer contour of a component and/or beingadjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features oreffects in this disclosure is intended to simply mean—for a structuralfeature: that a majority or major portion of such feature exhibits thecharacteristic in question, and—for a functional feature or an effect:that a majority of outcomes involving the characteristic provide theeffect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices. Further,methods related to the ostomy system and devices thereof are disclosed.An accessory device (also referred to as an external device) may be amobile phone or other handheld device. An accessory device may be apersonal electronic device, e.g. a wearable, such as a watch or otherwrist-worn electronic device. An accessory device may be a dockingstation. The docking station may be configured to electrically and/ormechanically couple the monitor device to the docking station. Thedocking station may be configured for charging the monitor device and/orconfigured for transferring data between the monitor device and thedocking station. The ostomy system may comprise a server device. Theserver device may be operated and/or controlled by the ostomy appliancemanufacturer and/or a service centre.

The present disclosure provides an ostomy system and devices thereof,such as an ostomy appliance, a base plate for an ostomy appliance, amonitor device, and optionally one or more accessory devices whicheither alone or together facilitate reliable determination of thenature, severity and rapidness of moisture propagation in the adhesivematerial provided for attaching the base plate to the skin surface of auser. Depending on the nature of the pattern of moisture propagation inthe adhesive, the ostomy system and devices thereof enable providinginformation to the user about the type of failure, and in turn enableproviding an indication to the user of the severity and thus theremaining time frame for replacing the ostomy appliance withoutexperiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (alsoreferred to as an ostomy bag). The ostomy appliance may be a colostomyappliance, an ileostomy appliance or a urostomy appliance. The ostomyappliance may be a two-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be releasably coupled e.g. with a mechanical and/oran adhesive coupling, e.g. to allow that a plurality of ostomy pouchescan be utilized (exchanged) with one base plate. Further, a two-partostomy appliance may facilitate correct application of the base plate toskin, e.g. to an improved user sight of the stomal region. The ostomyappliance may be a one-part ostomy appliance, i.e. the base plate andthe ostomy pouch may be fixedly attached to each other. The base plateis configured for coupling to a user's stoma and/or skin surrounding thestoma, such as a peristomal skin area.

The ostomy appliance includes a base plate, such as a monolithic,one-piece base plate, e.g. integrated with a sensor assembly part, or abase plate and a separate sensor assembly part, such as a sensorassembly part to be subsequently applied to a base plate. For example,to allow an arbitrary base plate, such as a conventional base plate, toachieve the features as described herein. Features as described withrespect to the base plate herein may be provided by a sensor assemblypart to be applied to a base plate, e.g. by the user. A sensor assemblypart may be adapted to adhere to an ostomy plate.

A disclosed method of attaching a base plate to a user's stoma and/orskin surrounding the stoma, such as the peristomal skin area, maycomprise attaching a sensor assembly part to a base plate and attachingthe base plate, e.g. together with the attached sensor assembly part, tothe user's stoma and/or skin surrounding the stoma, such as theperistomal skin area. Alternatively, the method of attaching the baseplate to the user's stoma and/or skin surrounding the stoma may compriseattaching the sensor assembly part to the user's stoma and/or skinsurrounding the stoma and attaching the base plate to the user's stomaand/or skin surrounding the stoma above the attached sensor assemblypart.

The base plate and/or the sensor assembly part comprises a firstadhesive layer, also denoted center adhesive layer. During use, thefirst adhesive layer adheres to the user's skin (peristomal area) and/orto additional seals, such as sealing paste, sealing tape and/or sealingring. Thus, the first adhesive layer may be configured for attachment ofthe base plate and/or the sensor assembly part to the skin surface of auser. The first adhesive layer may have a stomal opening, such as afirst adhesive stomal opening, with a center point.

The first adhesive layer may be made of a first composition. The firstcomposition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The first composition may comprise one or morehydrocolloids.

The first composition may comprise one or more water soluble or waterswellable hydrocolloids. The first composition may be a pressuresensitive adhesive composition suitable for medical purposes comprisinga rubbery elastomeric base and one or more water soluble or waterswellable hydrocolloids. The first composition may comprise one or morepolybutenes, one or more styrene copolymers, one or more hydrocolloids,or any combination thereof. The combination of the adhesive propertiesof the polybutenes and the absorbing properties of the hydrocolloidsrenders the first composition suitable for use in ostomy appliances. Thestyrene copolymer may for example be a styrene-butadiene-styrene blockcopolymer or a styrene-isoprene-styrene block copolymer. Preferably, oneor more styrene-isoprene-styrene (SIS) block type copolymers areemployed. The amount of styrene block-copolymer may be from 5% to 20% ofthe total adhesive composition.

The butene component is suitably a conjugated butadiene polymer selectedfrom polybutadiene, polyisoprene. The polybutenes are preferably presentin an amount of from 35-50% of the total adhesive composition.Preferably, the polybutene is polyisobutylene (PIB). Suitablehydrocolloids for incorporation in the first composition are selectedfrom naturally occurring hydrocolloids, semisynthetic hydrocolloids andsynthetic hydrocolloids. The first composition may comprise 20-60%hydrocolloids. A preferred hydrocolloid is carboxymethylcellulose (CMC).The first composition may optionally contain other components, such asfillers, tackifiers, plasticizers, and other additives.

The first adhesive layer may have a plurality of sensor point openings.A sensor point opening of the first adhesive layer is optionallyconfigured to overlap a part of an electrode, e.g. to form a sensorpoint.

The sensor point openings of the first adhesive layer may compriseprimary sensor point openings. The primary sensor point openings maycomprise one or more primary first sensor point openings and one or moreprimary second sensor point openings, the primary first sensor pointopenings configured to overlap parts of an electrode and the primarysecond sensor point openings configured to overlap parts of anotherelectrode different from the electrode at least partly overlapped by theprimary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisesecondary sensor point openings. The secondary sensor point openings maycomprise one or more secondary first sensor point openings and one ormore secondary second sensor point openings, the secondary first sensorpoint openings configured to overlap parts of an electrode and thesecondary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprisetertiary sensor point openings. The tertiary sensor point openings maycomprise one or more tertiary first sensor point openings and one ormore tertiary second sensor point openings, the tertiary first sensorpoint openings configured to overlap parts of an electrode and thetertiary second sensor point openings configured to overlap parts ofanother electrode different from the electrode at least partlyoverlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. Thefirst adhesive layer may have a thickness in the range from 0.1 mm to1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm.

The first adhesive layer may have a primary thickness in a primary partof the first adhesive layer, e.g. in a primary region within a primaryradial distance or in a primary radial distance range from the centerpoint of the stomal opening. The primary thickness may be in the rangefrom 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distancemay be in the range from 20 mm to 50 mm, such as in the range from 25 mmto 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondarypart of the first adhesive layer, e.g. in a secondary region outside asecondary radial distance or in a secondary radial distance range fromthe center point of the stomal opening. The secondary thickness may bein the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondaryradial distance may be in the range from 20 mm to 50 mm, such as in therange from 25 mm to 35 mm, e.g. 30 mm.

The base plate and/or the sensor assembly part may comprise a secondlayer. The second layer may be a second adhesive layer, also denoted rimadhesive layer. The second layer may have a second radial extension thatis larger than a first radial extension of the first adhesive layer atleast in a first angular range of the base plate and/or the sensorassembly part. Accordingly, a part of a proximal surface of the secondlayer may be configured for attachment to the skin surface of a user.The part of a proximal surface of the second layer configured forattachment to the skin surface of a user is also denoted the skinattachment surface of the second adhesive layer. The second layer mayhave a stomal opening, such as a second layer stomal opening and/or asecond adhesive stomal opening, with a center point.

The second adhesive layer may be made of a second composition. Thesecond composition may comprise one or more polyisobutenes and/orstyrene-isoprene-styrene. The second composition may comprise one ormore hydrocolloids.

The second composition may comprise one or more water soluble or waterswellable hydrocolloids. The second composition may be a pressuresensitive adhesive composition suitable for medical purposes comprisinga rubbery elastomeric base and one or more water soluble or waterswellable hydrocolloids. The second composition may comprise one or morepolybutenes, one or more styrene copolymers, one or more hydrocolloids,or any combination thereof. The combination of the adhesive propertiesof the polybutenes and the absorbing properties of the hydrocolloidsrenders the second composition suitable for use in ostomy appliances.The styrene copolymer may for example be a styrene-butadiene-styreneblock copolymer or a styrene-isoprene-styrene block copolymer.Preferably, one or more styrene-isoprene-styrene (SIS) block typecopolymers are employed. The amount of styrene block-copolymer may befrom 5% to 20% of the total adhesive composition. The butene componentis suitably a conjugated butadiene polymer selected from polybutadiene,polyisoprene. The polybutenes are preferably present in an amount offrom 35-50% of the total adhesive composition. Preferably, thepolybutene is polyisobutylene (PIB). Suitable hydrocolloids forincorporation in the second composition are selected from naturallyoccurring hydrocolloids, semisynthetic hydrocolloids and synthetichydrocolloids. The second composition may comprise 20-60% hydrocolloids.A preferred hydrocolloid is carboxymethylcellulose (CMC). The secondcomposition may optionally contain other components, such as fillers,tackifiers, plasticizers, and other additives.

Different ratio of contents may change properties of the first and/orsecond adhesive layers. The second adhesive layer and the first adhesivelayer may have different properties. The second adhesive layer (secondcomposition) and the first adhesive layer (first composition) may havedifferent ratios of polyisobutenes, styrene-isoprene-styrene, and/orhydrocolloids. For example, the second adhesive layer may provide astronger attachment to the skin compared to attachment to the skinprovided by the first adhesive layer. Alternatively or additionally, thesecond adhesive layer may be thinner than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lesswater and/or sweat absorbing than the first adhesive layer.Alternatively or additionally, the second adhesive layer may be lessmouldable than the first adhesive layer. The second adhesive layer mayprovide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The secondlayer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. inthe range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate and/or the sensor assembly part may comprise one or moreelectrodes, such as a plurality of electrodes, such as two, three, four,five, six, seven or more electrodes. The sensor assembly part may beapplied to the base plate, such as to provide the base plate with theone or more electrodes.

The electrodes, e.g. some or all the electrodes, may be arranged betweenthe first adhesive layer and the second adhesive layer. The electrodesmay be arranged in an electrode assembly, e.g. an electrode layer. Anelectrode comprises a connection part for connecting the electrodes toother components and/or interface terminals. An electrode may compriseone or more conductor parts and/or one or more sensing parts. Theelectrode assembly may be arranged between the first adhesive layer andthe second adhesive layer. The base plate and/or the sensor assemblypart, e.g. the electrode assembly, may comprise a first electrode, asecond electrode and optionally a third electrode. The base plate and/orthe sensor assembly part, e.g. the electrode assembly, may comprise afourth electrode and/or a fifth electrode. The base plate and/or thesensor assembly part, e.g. the electrode assembly, optionally comprisesa sixth electrode. The base plate and/or the sensor assembly part, e.g.the electrode assembly, may comprise a ground electrode. The groundelectrode may comprise a first electrode part. The first electrode partof the ground electrode may form a ground for the first electrode. Theground electrode may comprise a second electrode part. The secondelectrode part of the ground electrode may form a ground for the secondelectrode. The ground electrode may comprise a third electrode part. Thethird electrode part of the ground electrode may form a ground for thethird electrode. The ground electrode may comprise a fourth electrodepart. The fourth electrode part of the ground electrode may form aground for the fourth electrode and/or the fifth electrode.

The ground electrode or electrode parts of the ground electrode may beconfigured as or form a (common) reference electrode for some or all ofthe other electrodes of the electrode assembly. The ground electrode mayalso be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or moreof metallic (e.g. silver, copper, gold, titanium, aluminium, stainlesssteel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), andcarbonaceous (e.g. carbon black, carbon nanotube, carbon fibre,graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The firstelectrode and the ground electrode (e.g. first electrode part of theground electrode) may form a first sensor or first electrode pair. Thesecond electrode and the ground electrode (e.g. second electrode part ofthe ground electrode) may form a second sensor or second electrode pair.The third electrode and the ground electrode (e.g. third electrode partof the ground electrode) may form a third sensor or third electrodepair. The fourth electrode and the ground electrode (e.g. fourthelectrode part of the ground electrode) may form a fourth sensor orfourth electrode pair. The fifth electrode and the ground electrode(e.g. fifth electrode part of the ground electrode) may form a fifthsensor or fifth electrode pair.

The first electrode may form an open loop. The second electrode may forman open loop and/or the third electrode may form an open loop. Thefourth electrode may form an open loop. The fifth electrode may form anopen loop. Open loop electrode(s) enables electrode arrangement in fewor a single electrode layer.

The electrode assembly may comprise a support layer, also denoted asupport film. One or more electrodes may be formed, e.g. printed, on theproximal side of the support layer. One or more electrodes may beformed, e.g. printed, on the distal side of the support layer. Theelectrode assembly, such as the support layer of the electrode assembly,may have a stomal opening, such as an electrode assembly stomal openingand/or a support layer stomal opening, with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF)and/or ceramic (e.g. alumina, silica) materials. In one or moreexemplary base plates and/or sensor assembly parts, the support layer ismade of thermoplastic polyurethane (TPU). The support layer material maybe made of or comprise one or more of polyester, a thermoplasticelastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA),polyurea, and silicones.

Exemplary thermoplastic elastomers of the support layer are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate and/or the sensor assembly part, such as the electrodeassembly may comprise a masking element configured to insulate at leastparts of the electrodes from the first adhesive layer of the base plateand/or the sensor assembly part. The masking element may comprise one ormore, such as a plurality of, sensor point openings. The sensor pointopenings may comprise primary sensor point openings and/or secondarysensor point openings. The sensor point openings may comprise tertiarysensor point opening(s). The sensor point openings may comprisequaternary sensor point opening(s) A sensor point opening of the maskingelement overlaps at least one electrode of the electrode assembly whenseen in the axial direction, e.g. to form a sensor point. For example, aprimary sensor point opening may overlap a part of the ground electrodeand/or a part of the fourth electrode. A secondary sensor point openingmay overlap a part of the fourth electrode and/or a part of the fifthelectrode. A tertiary sensor point opening may overlap a part of thefifth electrode and/or a part of the ground electrode.

The masking element may comprise one or more, such as a plurality of,terminal openings. The masking element may comprise polymeric (e.g.polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica)materials. In one or more exemplary base plates and/or sensor assemblyparts, the masking element is made of or comprises thermoplasticpolyurethane (TPU). In one or more exemplary base plates and/or sensorassembly parts, the masking element is made of or comprises polyester.The masking element material may be made of or comprise one or more ofpolyester, a thermoplastic elastomer (TPE), polyimide, polyimide,Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenicblock copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO,TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplasticpolyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), andthermoplastic polyamides (TPA, TPE-A).

The base plate and/or the sensor assembly part may comprise a firstintermediate element. The first intermediate element may be arrangedbetween the electrodes/electrode layer and the first adhesive layerand/or between the second layer and the first adhesive layer. The firstintermediate layer may be made of an insulating material.

The base plate and/or the sensor assembly part may comprise a releaseliner. The release liner is a protective layer that protects adhesivelayer(s) during transport and storage and is peeled off by the userprior to applying the base plate and/or the sensor assembly part on theskin. The release liner may have a stomal opening, such as a releaseliner stomal opening, with a center point.

The base plate and/or the sensor assembly part may comprise a top layer.The top layer is a protective layer protecting the adhesive layer(s)from external strains and stress when the user wears the ostomyappliance. The electrodes, e.g. some or all the electrodes, may bearranged between the first adhesive layer and the top layer. The toplayer may have a stomal opening, such as a top layer stomal opening,with a center point. The top layer may have a thickness in the rangefrom 0.01 mm to 1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, suchas 0.04 mm.

The base plate and/or the sensor assembly part may comprise a monitorinterface. The monitor interface may be configured for electricallyand/or mechanically connecting the ostomy appliance (base plate and/orsensor assembly part) to the monitor device. The monitor interface maybe configured for wirelessly connecting the ostomy appliance (base plateand/or sensor assembly part) to the monitor device. Thus, the monitorinterface of the base plate and/or the sensor assembly part isconfigured to electrically and/or mechanically couple the ostomyappliance and the monitor device.

The monitor interface of the base plate and/or the sensor assembly partmay comprise, e.g. as part of a first connector of the monitorinterface, a coupling part for forming a mechanical connection, such asa releasable coupling between the monitor device and the base plateand/or the sensor assembly part. The coupling part may be configured toengage with a coupling part of the monitor device for releasablycoupling the monitor device to the base plate and/or the sensor assemblypart.

The monitor interface of the base plate and/or the sensor assembly partmay comprise, e.g. as part of a first connector of the monitorinterface, a plurality of terminals, such as two, three, four, five,six, seven or more terminals, for forming electrical connections withrespective terminals of the monitor device. The monitor interface maycomprise a ground terminal element forming a ground terminal. Themonitor interface may comprise a first terminal element forming a firstterminal, a second terminal element forming a second terminal andoptionally a third terminal element forming a third terminal. Themonitor interface may comprise a fourth terminal element forming afourth terminal and/or a fifth terminal element forming a fifthterminal. The monitor interface optionally comprises a sixth terminalelement forming a sixth terminal. The terminal elements of the monitorinterface may contact respective electrodes of the base plate and/or thesensor assembly part, such as the electrode assembly of the base plateand/or the sensor assembly part. The first intermediate element may bearranged between the terminal elements and the first adhesive layer. Thefirst intermediate element may cover or overlap terminal element(s) ofthe base plate and/or the sensor assembly part when seen in the axialdirection. Thus, the first adhesive layer may be protected or experiencemore evenly distributed mechanical stress from the terminal elements ofthe base plate and/or the sensor assembly part, in turn reducing therisk of terminal elements penetrating or otherwise damaging the firstadhesive layer. The first intermediate element may protect ormechanically and/or electrically shield the first adhesive layer fromthe terminal elements of the base plate and/or the sensor assembly part.

A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal end and a proximalend. A terminal element, such as the ground terminal element, the firstterminal element, the second terminal element, the third terminalelement, the fourth terminal element, the fifth terminal element and/orthe sixth terminal element, may comprise a distal part, a centre part,and/or a proximal part. The distal part may be between the distal endand the centre part. The proximal part may be between the proximal endand the centre part. A terminal element, such as the ground terminalelement, the first terminal element, the second terminal element, thethird terminal element, the fourth terminal element, the fifth terminalelement and/or the sixth terminal element, may be gold plated copper.

The base plate may comprise a coupling ring or other coupling member forcoupling an ostomy pouch to the base plate (two-part ostomy appliance).The center point may be defined as a center of the coupling ring.

The base plate and/or the sensor assembly part may have a stomalopening, e.g. with a center point. The stomal opening of the base plateand/or the sensor assembly part may be formed collectively of stomalopening(s) of the layers of the base plate and/or the sensor assemblypart, such as of the top layer, the first adhesive layer, the secondlayer and/or the sensor assembly part. The stomal opening(s) of thelayers of the base plate and/or the sensor assembly part, such as of thetop layer, the first adhesive layer, the second layer and/or the sensorassembly part may be aligned to form the stomal opening of the baseplate and/or the sensor assembly part. The stomal opening may be athrough-going passage of the base plate and/or the sensor assembly part.The stomal opening may be arranged substantially in the center of thebase plate and/or the sensor assembly part. The stomal opening(s) of thelayers of the base plate and/or the sensor assembly part may be arrangedsubstantially in the center of the respective layer. The stomal openingmay be configured to receive a stoma of the user and/or the stomalopening may be configured to allow output from the stoma to pass throughthe stomal opening an into an ostomy pouch attached to the base plate.For example, the stomal opening may be configured to allow passage ofoutput from a proximal side of the base plate and/or sensor assemblypart to a distal side of the base plate and/or sensor assembly part. Thesize and/or shape of the stomal opening may typically be adjusted by theuser or nurse before application of the ostomy appliance to accommodatethe user's stoma. In one or more exemplary base plates or sensorassembly parts, the user forms the stomal opening during preparation ofthe base plate and/or the sensor assembly part for application.

The monitor device comprises a processor and one or more interfaces,such as a first interface and/or a second interface. The monitor devicemay comprise a memory for storing ostomy data.

In one or more exemplary monitor devices, the processor is configured toapply a processing scheme, the first interface is connected to theprocessor and the memory, and the first interface is configured forcollecting ostomy data from the base plate and/or the sensor assemblypart coupled to the first interface. The ostomy data may comprise one ormore, such as all, of first ostomy data from a first electrode pair ofthe base plate and/or the sensor assembly part, second ostomy data froma second electrode pair of the base plate and/or the sensor assemblypart, and third ostomy data from a third electrode pair of the baseplate and/or the sensor assembly part. A second interface is connectedto the processor. To apply a processing scheme may comprise one or moreof obtain first parameter data based on the first ostomy data; obtainsecond parameter data based on the second ostomy data; and obtain thirdparameter data based on the third ostomy data. To apply a processingscheme may comprise determine an operating state of the base plate ofthe ostomy appliance based on one or more, such as all, of the firstparameter data, the second parameter data and the third parameter data.The operating state may be indicative of a degree of radial erosion ofthe base plate and/or the sensor assembly part, such as of the firstadhesive layer, and/or an acute leakage risk for the ostomy appliance.The monitor device is configured to, in accordance with a determinationthat the operating state is a first operating state, transmit a firstmonitor signal comprising monitor data indicative of the first operatingstate of the base plate via the second interface; and/or in accordancewith a determination that the operating state is a second operatingstate, transmit a second monitor signal comprising monitor dataindicative of the second operating state of the base plate via thesecond interface.

In one or more exemplary monitor devices, the first operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate and/or the sensor assembly part has experienceda first degree of radial erosion, e.g. the first adhesive layer iseroded to a first radial distance of the first electrode pair but not toa second radial distance of the second electrode pair.

In one or more exemplary monitor devices, the second operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate and/or the sensor assembly part has experienceda second degree of radial erosion, e.g. the first adhesive layer iseroded to the second radial distance of the second electrode pair butnot to a third radial distance of the third electrode pair.

To obtain first parameter data based on the first ostomy data maycomprise determining one or more first parameters based on the firstostomy data. To obtain second parameter data based on the second ostomydata may comprise determining one or more second parameters based on thesecond ostomy data. To obtain third parameter data based on the thirdostomy data may comprise determining one or more third parameters basedon the third ostomy data. In one or more exemplary monitor devices,determination of an operating state may be based on one or more firstparameters, such as first primary parameter and/or first secondaryparameter of first parameter data. In one or more exemplary monitordevices, determination of an operating state may be based on one or moresecond parameters, such as second primary parameter and/or secondsecondary parameter of the second parameter data. In one or moreexemplary monitor devices, determination of an operating state may bebased on one or more third parameters, such as third primary parameterand/or third secondary parameter of the third parameter data. In one ormore exemplary monitor devices, determination of an operating state maybe based on one or more fourth parameters, such as fourth primaryparameter and/or fourth secondary parameter of the fourth parameterdata.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of resistance between the firstelectrode pair, the second electrode pair, and the third electrode pair,respectively.

The first parameter data, the second parameter data, and the thirdparameter data may be indicative of a rate of change in resistancebetween the first electrode pair, the second electrode pair, and thethird electrode pair, respectively.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a first criteria set based on thefirst parameter data and/or the second parameter data, wherein theoperating state is determined to be the first operating state if thefirst criteria set is satisfied. The first criteria set may comprise oneor more first criteria based on one or more of first parameter data,second parameter data and third parameter data. The first criteria setmay comprise a first primary criterion based on the first parameterdata. The first criteria set may comprise a first secondary criterionbased on the second parameter data. The first criteria set may comprisea first tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate may be based on a first threshold set comprisingone or a plurality of first threshold values. The first threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the first criteria set. The first threshold set may comprise a firstprimary threshold value. The first threshold set may comprise a firstsecondary threshold value.

The first threshold set may comprise a first tertiary threshold value.

The first criteria set may be given by

(P_1_1<TH_1_1),

(P_2_1>TH_1_2), and

(P_3_1>TH_1_3),

wherein P_1_1 is a first primary parameter based on the first parameterdata, TH_1_1 is a first primary threshold value, P_2_1 is a secondprimary parameter based on the second parameter data, TH_1_2 is a firstsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data, and TH_1_3 is a first tertiary thresholdvalue, and wherein the first operating state is indicative of low degreeof radial erosion on the base plate and/or the sensor assembly part. Thefirst threshold values (TH_1_1, TH_1_2 and TH_1_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate and/or the sensor assembly part. The first tertiary criterion(P_3_1<TH_1_3) may be omitted in the first criteria set.

The first primary parameter P_1_1 may be indicative of the resistancebetween the first electrode pair (first electrode and first electrodepart of the ground electrode) of the base plate and/or the sensorassembly part.

The second primary parameter may be indicative of the resistance betweenthe second electrode pair (second electrode and second electrode part ofthe ground electrode) of the base plate and/or the sensor assembly part.

The third primary parameter may be indicative of resistance between thethird electrode pair (third electrode and third electrode part of theground electrode) of the base plate and/or the sensor assembly part.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second criteria set based on thesecond parameter data and/or the third parameter data, wherein theoperating state is determined to be the second operating state if thesecond criteria set is satisfied. The second criteria set may be basedon the first parameter data.

The second criteria set may comprise one or more second criteria basedon one or more of first parameter data, second parameter data and thirdparameter data. The second criteria set may comprise a second primarycriterion based on the first parameter data. The second criteria set maycomprise a second secondary criterion based on the second parameterdata. The second criteria set may comprise a second tertiary criterionbased on the third parameter data.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a second threshold set comprisingone or a plurality of second threshold values. The second threshold setmay comprise one or a plurality of threshold values, e.g. to be appliedin the second criteria set. The second threshold set may comprise asecond primary threshold value. The second threshold set may comprise asecond secondary threshold value. The second threshold set may comprisea second tertiary threshold value.

The second criteria set may be given by

(P_1_1<TH_2_1),

(P_2_1<TH_2_2), and

(P_3_1>TH_2_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_2_1 is a second primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_2_2 is a secondsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_2_3 is a second tertiary threshold value, andwherein the second operating state is indicative of medium degree ofradial erosion on the base plate and/or the sensor assembly part. Thesecond threshold values (TH_2_1, TH_2_2 and TH_2_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate and/or the sensor assembly part. The second primary criterion(P_1_1<TH_2_1) and/or the second tertiary criterion (P_3_1>TH_2_3) maybe omitted in the second criteria set.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a default criteria set based on thefirst parameter data, wherein the operating state is determined to bethe default operating state if the default criteria set is satisfied,and in accordance with a determination that the operating state is thedefault operating state, transmit a default monitor signal comprisingmonitor data indicative of the default operating state of the ostomyappliance.

The default criteria set may be given by

(P_1_1>TH_D_1),

(P_2_1>TH_D_2), and

(P_3_1>TH_D_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_D_1 is a default primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_D_2 is a defaultsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_D_3 is a default tertiary threshold value, andwherein the default operating state is indicative of very low or nodegree of radial erosion on the base plate and/or the sensor assemblypart. The default threshold values (TH_D_1, TH_D_2 and TH_D_3) may bethe same or different, e.g. depending on the electrode configuration ofthe base plate and/or the sensor assembly part.

In one or more exemplary monitor devices, to determine an operatingstate of the base plate is based on a third criteria set based on thethird parameter data, wherein the operating state is determined to bethe third operating state if the third criteria set is satisfied, and inaccordance with a determination that the operating state is the thirdoperating state, transmit a third monitor signal comprising monitor dataindicative of the third operating state of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state ofthe base plate corresponds to a situation wherein the first adhesivelayer of the base plate and/or the sensor assembly part has experienceda third degree of radial erosion, e.g. the first adhesive layer iseroded to the third radial distance of the third electrode pair.

The third criteria set may be given by

(P_1_1<TH_3_1),

(P_2_1<TH_3_2), and

(P_3_1<TH_3_3)

wherein P_1_1 is a first primary parameter based on the first parameterdata and indicative of the resistance between the first electrode pair,TH_3_1 is a third primary threshold value, P_2_1 is a second primaryparameter based on the second parameter data and indicative of theresistance between the second electrode pair, TH_3_2 is a thirdsecondary threshold value, P_3_1 is a third primary parameter based onthe third parameter data and indicative of the resistance between thethird electrode pair, TH_3_3 is a third tertiary threshold value, andwherein the third operating state is indicative of high degree of radialerosion on the base plate and/or the sensor assembly part. The thirdthreshold values (TH_3_1, TH_3_2 and TH_3_3) may be the same ordifferent, e.g. depending on the electrode configuration of the baseplate and/or the sensor assembly part. The third primary criterion(P_1_1<TH_3_1) and/or the third secondary criterion (P_2_1<TH_3_2) maybe omitted in the third criteria set.

In one or more exemplary monitor devices, the ostomy data comprisesfourth ostomy data from a fourth electrode pair of the base plate and/orthe sensor assembly part. To apply a processing scheme may comprise toobtain fourth parameter data based on the fourth ostomy data, anddetermine an operating state of the base plate of the ostomy appliancebased on the fourth parameter data. The monitor device may be configuredto, in accordance with a determination that the operating state is afourth operating state, transmit a fourth monitor signal comprisingmonitor data indicative of the fourth operating state of the ostomyappliance.

In one or more exemplary monitor devices, the fourth operating state ofthe base plate corresponds to a situation, wherein the fourth electrodepair detects fluid, such as output, between the distal surface of firstadhesive layer and the skin of the user at a fourth radial distance, andthus there is a high risk of leakage from the ostomy appliance in thefourth operating state.

The fourth criteria set may be given by

(P_4_1<TH_4_4)

wherein P_4_1 is a fourth primary parameter based on the fourthparameter data and indicative of the resistance between the fourthelectrode pair and TH_4_4 is a fourth quaternary threshold value, andwherein the fourth operating state is indicative of high risk of leakagefrom the ostomy appliance.

The monitor device comprises a monitor device housing optionally made ofa plastic material. The monitor device housing may be an elongatehousing having a first end and a second end. The monitor device housingmay have a length or maximum extension along a longitudinal axis in therange from 1 cm to 15 cm. The monitor device housing may have a width ormaximum extension perpendicular to the longitudinal axis in the rangefrom 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface. The first interface maybe configured as an appliance interface for electrically and/ormechanically connecting the monitor device to the ostomy appliance.Thus, the appliance interface is configured to electrically and/ormechanically couple the monitor device and the ostomy appliance. Thefirst interface may be configured as an accessory device interface forelectrically and/or mechanically connecting the monitor device to anaccessory device, such as a docking station. The first interface may beconfigured for coupling to a docking station of the ostomy system, e.g.for charging the monitor device and/or for data transfer between themonitor device and the docking station.

The first interface of the monitor device may comprise a plurality ofterminals, such as two, three, four, five, six, seven or more terminals,for forming electrical connections with respective terminals and/orelectrodes of the ostomy appliance. One or more terminals of the firstinterface may be configured for forming electrical connections with anaccessory device, e.g. with respective terminals of a docking station.The first interface may comprise a ground terminal. The first interfacemay comprise a first terminal, a second terminal and optionally a thirdterminal. The first interface may comprise a fourth terminal and/or afifth terminal. The first interface optionally comprises a sixthterminal. In one or more exemplary monitor devices, the first interfacehas M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling part(may alternatively be denoted a device coupling part or a monitor devicecoupling part) for forming a mechanical connection, such as a releasablecoupling between the monitor device and the base plate and/or the sensorassembly part. The coupling part and the terminals of the firstinterface form (at least part of) a first connector of the monitordevice.

The monitor device comprises a power unit for powering the monitordevice. The power unit may comprise a battery. The power unit maycomprise charging circuitry connected to the battery and terminals ofthe first interface for charging the battery via the first interface,e.g. the first connector. The first interface may comprise separatecharging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensor.The sensor unit is connected to the processor for feeding sensor data tothe processor. The sensor unit may comprise an accelerometer for sensingacceleration and provision of acceleration data to the processor. Thesensor unit may comprise a temperature sensor for provision oftemperature data to the processor.

The monitor device comprises a second interface connected to theprocessor. The second interface may be configured as an accessoryinterface for connecting, e.g. wirelessly connecting, the monitor deviceto one or more accessory devices. The second interface may comprise anantenna and a wireless transceiver, e.g. configured for wirelesscommunication at frequencies in the range from 2.4 to 2.5 GHz. Thewireless transceiver may be a Bluetooth transceiver, i.e. the wirelesstransceiver may be configured for wireless communication according toBluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth5. The second interface optionally comprises a loudspeaker and/or ahaptic feedback element for provision of an audio signal and/or hapticfeedback to the user, respectively.

In one or more exemplary ostomy systems, the monitor device forms anintegrated part of the ostomy appliance, e.g. the monitor device mayform an integrated part of a base plate and/or the sensor assembly partof the ostomy appliance.

The ostomy system may comprise a docking station forming an accessorydevice of the ostomy system. The docking station may be configured toelectrically and/or mechanically couple the monitor device to thedocking station.

The docking station may comprise a docking monitor interface. Thedocking monitor interface may be configured for electrically and/ormechanically connecting the monitor device to the docking station. Thedocking monitor interface may be configured for wirelessly connectingthe monitor device to the docking station. The docking monitor interfaceof the docking station may be configured to electrically and/ormechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, acoupling part for forming a mechanical connection, such as a releasablecoupling between the monitor device and the docking station. Thecoupling part may be configured to engage with a coupling part of themonitor device for releasably coupling the monitor device to the dockingstation.

The docking monitor interface of the docking station may comprise, e.g.as part of a first connector of the docking monitor interface, aplurality of terminals, such as two, three, four, five, six, seven ormore terminals, for forming electrical connections with respectiveterminals of the monitor device. The docking monitor interface maycomprise a ground terminal. The docking monitor interface may comprise afirst terminal and/or a second terminal. The docking station maycomprise a third terminal. The docking monitor interface may comprise afourth terminal and/or a fifth terminal. The docking monitor interfaceoptionally comprises a sixth terminal.

Disclosed is a base plate for an ostomy appliance, such as a base plateas described above. Also, a sensor assembly part for an ostomy applianceis disclosed, such as a sensor assembly part for being applied to a baseplate. The base plate and/or the sensor assembly part may comprise: atop layer, a first adhesive layer, an electrode assembly comprising aplurality of electrodes; and a monitor interface configured forconnecting the base plate and/or the sensor assembly part to a monitordevice, such as mechanically connecting and/or electrically connectingthe base plate and/or the sensor assembly part to a monitor device. Thebase plate and/or the sensor assembly part may comprise additionallayers and/or features as described above.

The electrode assembly may have a first part and a second part. Thefirst part may comprise connection parts of the plurality of electrodes,e.g. configured for connecting the plurality of electrodes to terminalsof a monitor device. The second part may comprise sensing parts of theplurality of electrodes. The electrode assembly, such as the second partof the electrode assembly, may be arranged between the first adhesivelayer and the top layer.

The monitor interface may comprise a plurality of terminals electricallyconnected to the plurality of electrodes and configured to connect withrespective terminals of the monitor device. The connection parts mayform the plurality of terminals of the monitor interface.

The top layer may comprise a top layer opening, e.g. configured to allowfor connection, such as electrical connection, between the plurality ofelectrodes of the electrode assembly and terminals of the monitordevice.

Also disclosed is a device for connecting to a base plate and/or asensor assembly part of an ostomy appliance, such as the above disclosedbase plate. The device may be a monitor device, e.g. such as a monitordevice as disclosed above. The monitor device may be configured tomeasure electrical parameters using electrodes of the base plate and/orsensor assembly part. The device may comprise electronic circuitry. Theelectronic circuitry may include a processor. The electronic circuitrymay be enclosed by the device housing.

The device may comprise an appliance interface, e.g. configured forconnecting the device to the base plate and/or the sensor assembly part.The appliance interface may comprise a plurality of terminals, e.g. forforming electrical connection with a plurality of electrodes of the baseplate and/or the sensor assembly part. The appliance interface maycomprise a device coupling part. The device coupling part may providefor coupling between the device and the base plate.

Also disclosed is a method for manufacturing a base plate or a sensorassembly part, such as a base plate or a sensor assembly part for anostomy appliance, such as the base plate or the sensor assembly part asdisclosed above.

The method may comprise: providing a top layer; providing an electrodeassembly comprising a plurality of electrodes; and providing a firstadhesive layer.

The electrode assembly may have a first part and a second part. Thefirst part may comprise connection parts of the plurality of electrodes,e.g. configured for connecting the plurality of electrodes to terminalsof a monitor device. The second part may comprise sensing parts of theplurality of electrodes.

The method may further comprise assembling the top layer, the electrodeassembly and the first adhesive layer, e.g. such that the electrodeassembly, such as the second part of the electrode assembly, is arrangedbetween the first adhesive layer and the top layer.

The method may further comprise providing a top layer opening in the toplayer. The top layer opening may be configured to allow for connection,such as electrical connection, between the plurality of electrodes ofthe electrode assembly and terminals of the monitor device.

By providing the top layer opening in the top layer, the electrodes ofthe electrode assembly may be accessible for connecting the monitordevice being exterior to the base plate and/or the sensor assembly part,to the electrode assembly. For example, a plurality of terminals of themonitor device may be connectable through the top layer opening to theplurality of electrodes of the electrode assembly, such as to theconnecting parts and/or terminals of the electrode assembly.

The top layer, the electrode assembly and/or the first adhesive layermay be substantially planar. The top layer, the electrode assemblyand/or the first adhesive layer may extend in a base plate plane and/orin a sensor assembly part plane.

A release liner may be provided on the proximal side of the firstadhesive layer. The first adhesive layer may be provided with a releaseliner on the proximal side of the first adhesive layer. The releaseliner may have a distal side facing the first adhesive layer. The firstadhesive layer may be provided, such as formed, on the release liner,such as on a distal side of the release liner, e.g. by scraping a thinlayer of a first composition, such as a first adhesive composition, ontothe release liner to form the first adhesive layer. The first adhesivelayer may be formed on the release liner prior to assembling the toplayer, the electrode assembly and the first adhesive layer.

The electrode assembly, such as the second part of the electrodeassembly, may be provided between the top layer and the first adhesivelayer. The electrode assembly may comprise proximal side and/or a distalside. A distal side of the electrode assembly may be facing the toplayer. A proximal side of the electrode assembly may be facing the firstadhesive layer.

The first part of the electrode assembly may extend through the toplayer opening. The first part of the electrode assembly may have twosubstantially parallel sides, e.g. in the base plate plane and/or in thesensor assembly part plane.

The plurality of electrodes may be provided and/or arranged on aproximal side of the electrode assembly. The electrode assembly maycomprise a support layer. The plurality of electrodes may be providedand/or arranged on the proximal side of the support layer. For example,the plurality of electrodes may be printed on the proximal side of thesupport layer. The plurality of electrodes may face the first adhesivelayer. The plurality of electrodes may contact the first adhesive layer.

The first part of the electrode assembly may have a primary side. Thefirst part of the electrode assembly may have a secondary side. Theprimary side of the first part of the electrode assembly may be aproximal side of the first part of the electrode assembly. The secondaryside of the first part of the electrode assembly may be a distal side ofthe first part of the electrode assembly. The primary side of the firstpart of the electrode assembly may initially be a proximal side of thefirst part of the electrode assembly. The secondary side of the firstpart of the electrode assembly may initially be a distal side of thefirst part of the electrode assembly. The first part of the electrodeassembly may be turned over, e.g. to expose the connection parts of theplurality of electrodes on a distal side of the base plate and/or thesensor assembly part. For example, the first part may be bend, e.g.between 170-190 degrees, such as 180 degrees, e.g. for the primary sideof the first part of the electrode assembly to face distally. Thus, theprimary side of the first part of the electrode assembly may, at leastpartly, be facing distally. The first part of the electrode assembly maybe turned over through the top layer opening. Turning over the firstpart of the electrode assembly may be of particular relevance when theplurality of electrodes is provided on the proximal side of theelectrode assembly.

The connection parts of each of the plurality of electrodes may extendfrom the proximal side of the electrode assembly to the distal side ofthe electrode assembly, such as through the support layer of theelectrode assembly. For example, the support layer may be provided withsmall holes at the first part of the electrode assembly to allowconnection with the connection parts at the distal side of the electrodeassembly.

The monitor interface may comprise a coupling part configured forforming a mechanical connection, such as a releasable coupling, betweenthe monitor device and the base plate and/or the sensor assembly part.For example, the coupling part may be a rigid coupling part. Thecoupling part may allow for an electrical connection between the monitordevice being coupled to the coupling part and the plurality ofelectrodes of the electrode assembly, such as through the plurality ofterminals of the monitor interface and the monitor device.

The coupling part may be attached to the top layer, such as a distalside of the top layer. Alternatively or additionally, the coupling partmay be attached to the electrode assembly, such as to a distal side ofthe electrode assembly, such as to a distal side of the support layer ofthe electrode assembly. The coupling part may be attached to the toplayer and/or the electrode assembly by gluing or welding. The couplingpart may extend through the top layer opening.

The coupling part may be aligned with the connection parts of theplurality of electrodes. The first part of the electrode assembly mayextend into the coupling part. The coupling part may be positioned tocover the connection parts of the plurality of electrodes. Alternativelyor additionally, the connection part of the plurality of electrodes maybe positioned within a terminal interface region defined by the couplingpart. The terminal interface region may be a region wherein terminals,e.g. of the base plate and/or sensor assembly part, may connect, such asmechanically and/or electrically connect, with respective terminals of amonitor device. The terminal interface region need not be a structurallydelimited and/or visible region. The terminal interface region may be aregion adjacent to the coupling part. Alternatively or additionally, Theterminal interface region may be surrounded by the coupling part, suchas a region surrounded by the coupling part. The terminal interfaceregion may be within a 20 mm radius of the coupling part, such as withina 10 mm radius of the coupling part, such as within a 5 mm radius of thecoupling part, such as within a 1 mm radius of the coupling part. Thecoupling part may surround the terminal interface region. The couplingpart may have one or more outer sides including a first outer side. Theterminal interface region may be adjacent an outer side of the couplingpart, such as the first outer side.

The electrode assembly may comprise a reinforcement element. Thereinforcement element may be forming at least part of the first part ofthe electrode assembly. The reinforcement element may provide and/orstrengthen the first part of the electrode assembly, e.g. to betteraccount for direct contact between the terminals of the monitor deviceand the attachment parts of the plurality of electrodes. Furthermore,the reinforcement element may facilitate bending of the first part ofthe electrode assembly, such as to turn the primary side of the firstpart of the electrode assembly to face distally.

The reinforcement element may comprise a plurality of conductive paths.The plurality of conductive paths may be connected to the plurality ofelectrodes, e.g. to form the connection parts of the plurality ofelectrodes. For example, the reinforcement element may be a flexcircuit. The plurality of conductive paths may extend along the entirelength of the reinforcement element.

The and/or the sensor assembly part may comprise a second adhesivelayer, such as the second adhesive layer as previously disclosed. Thesecond adhesive layer may have a proximal side and/or a distal side. Theproximal side of the second adhesive layer may be facing the distal sideof the electrode assembly. The distal side of the second adhesive layermay be facing the coupling part. The second adhesive layer may bebetween the top layer and the electrode assembly. The method maycomprise providing the second adhesive layer. The method may comprisepositioning the second adhesive layer, e.g. with a proximal side facingthe distal side of the electrode assembly. The second adhesive layer maybe provided, such as formed, on the proximal side of the top layer, e.g.such that the distal side of the second adhesive layer is facing theproximal side of the top layer. The distal side of the second adhesivelayer may be facing the proximal side of the top layer. The secondadhesive layer may be provided on the top layer by scraping a thin layerof a second composition, such as a second adhesive composition, onto thetop layer, such as on the proximal side of the top layer, to form thesecond adhesive layer.

The second adhesive layer may comprise a second adhesive layer opening,e.g. aligned with the top layer opening. The second adhesive layeropening may be configured to allow for connection, such as electricalconnection, between the plurality of electrodes of the electrodeassembly and terminals of the monitor device. For example, connection,such as electrical connection, between the plurality of electrodes ofthe electrode assembly and terminals of the monitor device may beprovided through the top layer opening and the second adhesive layeropening.

The second adhesive layer may extend over a larger area in the baseplate plane and/or in the sensor assembly part plane than the firstadhesive layer. For example, the second adhesive layer may extend over asecond area in the base plate plane/sensor assembly plane, e.g. beinglarger than the first area and/or covering the first area, where thefirst adhesive layer extends over the first area.

The top layer opening and/or the second adhesive layer opening may beU-shaped. For example, the top layer opening and/or the second adhesivelayer opening may be provided by cutting a U-shaped cut in the top layerand/or the second adhesive layer. For example, the top layer openingand/or the second adhesive layer opening may be provided by a U-shapedcut allowing the top layer and/or the second adhesive layer and theelectrode assembly below the top layer to be turned, such as for theelectrode assembly, such as the first part of the electrode assembly, toextend through the top layer opening and/or for the primary side of thefirst part of the electrode assembly to face distally.

The top layer opening and/or the second adhesive layer opening may beprovided in the top layer and/or second adhesive layer after assemblingthe top layer, the electrode assembly and the first adhesive layer andoptionally the second adhesive layer.

The base plate and/or the sensor assembly part may comprise a backelement. The back element may be provided between the first adhesivelayer and the electrode assembly and/or the plurality of electrodes ofthe electrode assembly. The back element may be provided between thefirst adhesive layer and the first part of the electrode assembly. Theback element may facilitate that a part of the electrode assembly, suchas the first part of the electrode assembly is not adhering to the firstadhesive layer, such as to allow the part, such as the first part, ofthe electrode assembly to be turned, such as to extend through the toplayer opening. The back element may be used as a stop for cutting of theopening, such as the U-shaped cut.

Alternatively or additionally, the top layer opening and/or the secondadhesive layer opening may be provided in the top layer and/or thesecond adhesive layer before assembling the top layer, the electrodeassembly and the first adhesive layer, and optionally the secondadhesive layer, such as before assembling the top layer and/or thesecond adhesive layer with the electrode assembly and/or the firstadhesive layer. For example, the top layer opening and/or the secondadhesive layer opening may be provided by a cutting or stamping a holein the top layer and/or second adhesive layer. The top layer opening andthe second adhesive layer opening may be provided simultaneously.

The base plate and/or the sensor assembly part may be cut from assembledlayers, e.g. comprising the top layer, the electrode assembly and/or thefirst adhesive layer. The method may comprise cutting out, such asstamping out, the base plate and/or the sensor assembly part from theassembled top layer, electrode assembly and first adhesive layer. Thecutting out may provide a contour of the base plate and/or the sensorassembly part. The cutting out may be provided before turning over thefirst part of the electrode assembly.

The base plate and/or the sensor assembly part may comprise a stomalopening with a center point. For example, the top layer, the secondadhesive, the electrode assembly, the first adhesive and/or the releaseliner may comprise a stomal opening with a center point, e.g.collectively forming the stomal opening with the center point of thebase plate and/or the sensor assembly part.

A horizontal axis in the base plate plane and/or the sensor assemblyplane may cross the center point, e.g. of the stomal opening. Thehorizontal axis may be orientated substantially horizontal, e.g.parallel with the ground, when the base plate is worn as intended. Anupper half of the base plate may be defined as the part of the baseplate in the base plate plane above the horizontal axis when the baseplate is worn as intended. A lower half of the base plate may be definedas the part of the base plate in the base plate plane below thehorizontal axis when the base plate is worn as intended.

The coupling part and/or the first part of the electrode assembly may bepositioned on the upper half of the base plate and/or sensor assemblypart. The coupling part and/or the first part of the electrode assemblymay be positioned on the upper half of the base plate and/or sensorassembly part within an angular space from the horizontal axis, e.g.with respect to the center point of the base plate, from 45-135 degrees,such as from 45-90 degrees, or from 90-135 degrees. Such positioning ofthe coupling part and/or the first part of the electrode assembly mayprovide that a device, such as the monitor device, may be coupled to thecoupling part and/or the first part of the electrode assembly withlittle or no interference with the ostomy bag. Furthermore, it may easeattachment of the device to the base plate.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1comprises an ostomy appliance 2 including a base plate 4. The base plate4 is adapted to support an ostomy pouch (not shown). Further, the ostomysystem 1 comprises a monitor device 6 and an accessory device 8 (mobiletelephone). The monitor device 6 is connectable to the base plate 4 viarespective first connectors of the monitor device 6 and base plate 4.The monitor device 6 is configured for wireless communication with theaccessory device 8. Optionally, the accessory device 8 is configured tocommunicate with a server device 10 of the ostomy system 1, e.g. vianetwork 12. The server device 10 may be operated and/or controlled bythe ostomy appliance manufacturer and/or a service centre. Ostomy dataor parameter data based on the ostomy data are obtained fromelectrodes/sensors of the ostomy appliance 2 with the monitor device 6.The monitor device 6 processes the ostomy data and/or parameter databased on the ostomy data to determine monitor data that are transmittedto the accessory device 8. In the illustrated ostomy system, theaccessory device 8 is a mobile phone, however the accessory device 8 maybe embodied as another handheld device, such as a tablet device, or awearable, such as a watch or other wrist-worn electronic device.Accordingly, the monitor device 6 is configured to determine andtransmit monitor data to the accessory device 8. The base plate 4comprises a coupling member 14 in the form of a coupling ring 16 forcoupling an ostomy pouch (not shown) to the base plate (two-part ostomyappliance). The base plate has a stoma-receiving opening 18 with a stomacenter point. The size and/or shape of the stomal opening 18 istypically adjusted by the user or nurse before application of the ostomyappliance to accommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming anaccessory device of the ostomy system 1. The docking station 20comprises a docking monitor interface including a first connector 22configured for electrically and/or mechanically connecting the monitordevice 6 to the docking station 20. The docking monitor interface may beconfigured for wirelessly connecting the monitor device to the dockingstation. The docking station 20 comprises a user interface 24 forreceiving user input and/or providing feedback to the user on theoperational state of the docking station 20. The user interface 24 maycomprise a touch-screen. The user interface 24 may comprise one or morephysical buttons and/or one or more visual indicators, such as lightemitting diodes,

FIG. 2 is a schematic block diagram of an exemplary monitor device. Themonitor device 6 comprises a monitor device housing 100, a processor 101and one or more interfaces, the one or more interfaces including a firstinterface 102 (appliance interface) and a second interface 104(accessory interface). The monitor device 6 comprises a memory 106 forstoring ostomy data and/or parameter data based on the ostomy data. Thememory 106 is connected to the processor 101 and/or the first interface102.

The first interface 102 is configured as an appliance interface forelectrically and/or mechanically connecting the monitor device 6 to theostomy appliance, e.g. ostomy appliance 2. The first interface 102comprises a plurality of terminals for forming electrical connectionswith respective terminals of the ostomy appliance 2 (base plate 4). Thefirst interface 102 comprises a ground terminal 108, a first terminal110, a second terminal 112 and a third terminal 114. The first interface102 optionally comprises a fourth terminal 116 and a fifth terminal 118.The first interface 102 of the monitor device 6 comprises a couplingpart 120 for forming a mechanical connection, such as a releasablecoupling between the monitor device and the base plate. The couplingpart 120 and the terminals 108, 110, 112, 114, 116, and 118 of the firstinterface 102 form (at least part of) a first connector of the monitordevice 6.

The monitor device 6 comprises a power unit 121 for powering the monitordevice and active components thereof, i.e. the power unit 121 isconnected to the processor 101, the first interface 102, the secondinterface 104, and memory 106. The power unit comprises a battery andcharging circuitry. The charging circuitry is connected to the batteryand terminals of the first interface 102 for charging the battery viaterminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessoryinterface for connecting the monitor device 6 to one or more accessorydevices such as accessory device 8. The second interface 104 comprisesan antenna 122 and a wireless transceiver 124 configured for wirelesscommunication with accessory device(s). Optionally, the second interface104 comprises a loudspeaker 126 and/or a haptic feedback element 128 forprovision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 comprises a sensor unit 140 connected to theprocessor 101. The sensor unit 140 comprises a temperature sensor forfeeding temperature data to the processor and a G-sensor oraccelerometer for feeding acceleration data to the processor 101.

The processor 101 is configured to apply a processing scheme, and thefirst interface 102 is configured for collecting ostomy data from thebase plate coupled to the first interface, the ostomy data comprisingfirst ostomy data from a first electrode pair of the base plate, secondostomy data from a second electrode pair of the base plate, and thirdostomy data from a third electrode pair of the base plate. The ostomydata may be stored in the memory 106 and/or processed in the processor101 in order to obtain parameter data. The parameter data may be storedin the memory 106. The processor 101 is configured to apply a processingscheme, wherein to apply a processing scheme comprises obtain firstparameter data based on the first ostomy data; obtain second parameterdata based on the second ostomy data; obtain third parameter data basedon the third ostomy data. In other words, the processor 101 isconfigured to obtain first, second and third parameter data based onrespective first, second and third ostomy data. To apply a processingscheme comprises to determine an operating state of the base plate ofthe ostomy appliance based on one or more, e.g. all, of the firstparameter data, the second parameter data and the third parameter data,wherein the operating state is indicative of a degree of radial erosionof the base plate and/or acute leakage risk for the ostomy appliance.The monitor device 6 is configured to, in accordance with adetermination that the operating state is a first operating state,transmit a first monitor signal comprising monitor data indicative ofthe first operating state of the base plate via the second interface;and in accordance with a determination that the operating state is asecond operating state, transmit a second monitor signal comprisingmonitor data indicative of the second operating state of the base platevia the second interface.

FIG. 3 illustrates an exploded view of an exemplary base plate of anostomy appliance. The base plate 4 comprises a first adhesive layer 200.During use, a proximal surface of the first adhesive layer 200 adheresto the user's skin in the peristomal area and/or to additional seals,such as sealing paste, sealing tape and/or sealing ring. The base plate4 optionally comprises a second adhesive layer 202, also denoted rimadhesive layer. The base plate 4 comprises a plurality of electrodesarranged in an electrode assembly 204. The electrode assembly 204 isarranged between the first adhesive layer 200 and the second adhesivelayer 202. The electrode assembly 204 comprises a support layer withelectrodes formed on a proximal surface of the support layer. The baseplate 4 comprises a release liner 206 that is peeled off by the userprior to applying the base plate 4 on the skin. The base plate 4comprises a top layer 208 and a coupling ring 209 for coupling an ostomypouch to the base plate 4. The top layer 208 is a protective layerprotecting the second adhesive layer 202 from external strains andstress during use.

The base plate 4 comprises a monitor interface. The monitor interface isconfigured for electrically and/or mechanically connecting the ostomyappliance (base plate 4) to the monitor device. The monitor interface ofthe base plate comprises a coupling part 210 for forming a mechanicalconnection, such as a releasable coupling between the monitor device andthe base plate. The coupling part 210 is configured to engage with acoupling part of the monitor device for releasably coupling the monitordevice to the base plate 4. Further, the monitor interface of the baseplate 4 comprises a plurality of terminal elements respectively forminga plurality of terminals 212 for forming electrical connections withrespective terminals of the monitor device. The coupling part 210 andthe terminals 212 form a first connector 211 of the base plate 4. Thebase plate 4 comprises a first intermediate element 213 on the proximalside of the electrode assembly. The first intermediate element 213 isarranged between the terminal elements forming terminals 212 and thefirst adhesive layer (not shown). The first intermediate element 213covers the terminal elements forming terminals 212 of the base plate 4when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plate.

As previously described, some parts of the illustrated base plate 4, maybe provided as a separate assembly to be applied to an existing baseplate, e.g. comprising one or more of the components as described, suchas to provide a base plate like the base plate 4 as described. Forexample, a sensor assembly part 700 may be provided, e.g. comprising theelectrode assembly 204, the first connector 211, the first intermediateelement 213, the first adhesive layer 200 and the release liner 206.Additionally, the sensor assembly part 700 may also comprise the secondadhesive layer 202 and/or the top layer 208. It may be envisioned thatthe user may provide a hole in layers of the base plate whereto thesensor assembly part 700 is to be applied, to allow for the firstconnector 211 of the sensor assembly part 700 to protrude through layersof the base plate whereto the sensor assembly part 700 is applied.Alternatively, the sensor assembly part 700 may be applied to the baseplate such that the first connector 211 is positioned outside theperiphery of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly204 of a base plate and/or a sensor assembly part. The electrodeassembly 204 has a distal side 204A and a proximal side 204B. Theelectrode assembly comprises a support layer 214 with proximal surface214B and electrodes 216 including a ground electrode, a first electrode,a second electrode, a third electrode, a fourth electrode, and a fifthelectrode, wherein each electrode has a respective connection part 217for connecting the electrodes 216 to respective terminal elements of themonitor interface. The electrodes 216 are provided, such as formed, on aproximal side 214B of the support layer 214, e.g. the electrodes 216 maybe positioned on the proximal side 214B of the support layer. Further,electrode assembly 204 comprises a masking element 218 with proximalsurface 218B and configured to insulate electrode parts of electrodes216 from the first adhesive layer of the base plate and/or the sensorassembly part. The masking element 218 covers or overlap with parts ofthe electrodes 216 when seen in the axial direction.

FIG. 5 is a proximal view of proximal surfaces of base plate parts ofthe base plate 4 and/or the sensor assembly part 700 without the firstadhesive layer and the release liner. The base plate 4 and/or the sensorassembly part 700 comprises a first intermediate element 213 on theproximal side of the electrode assembly, i.e. between the electrodeassembly 204 and the first adhesive layer (not shown). The firstintermediate element 213 covers the terminal elements of the base plate4 when seen in the axial direction and protects the first adhesive layerfrom mechanical stress from the terminal elements of the base plateand/or the sensor assembly part.

FIG. 6 is a distal view of an exemplary electrode configuration 220 ofelectrodes 216 of the electrode assembly 204. The electrode assembly204, such as the electrode configuration 220 of the electrode assembly204 comprises a ground electrode 222, a first electrode 224, a secondelectrode 226, a third electrode 228, a fourth electrode 230, and afifth electrode 232. The ground electrode 222 comprises a groundconnection part 222A and the first electrode 224 comprises a firstconnection part 224A. The second electrode 226 comprises a secondconnection part 226A and the third electrode 228 comprises a thirdconnection part 228A. The fourth electrode 230 comprises a fourthconnection part 230A and the fifth electrode 232 comprise a fifthconnection part 232A.

The fourth electrode 230 comprises fourth sensing parts 230B. The fifthelectrode 232 comprises fifth sensing parts 232B.

The ground electrode 222 comprises a first electrode part 234 forforming a ground for the first electrode 224. The ground electrode 222comprises a second electrode part 236 for forming a ground for thesecond electrode 226. The ground electrode 222 comprises a thirdelectrode part 238 for forming a ground for the third electrode 228. Theground electrode 222 comprises a fourth electrode part 240 for forming aground for the fourth electrode 230 and the fifth electrode 232. Thefourth electrode part 240 of the ground electrode 222 comprises groundsensing parts 222B

FIG. 7 is a distal view of an exemplary masking element. The maskingelement 218 optionally has a plurality of terminal openings includingsix terminal openings. The plurality of terminal openings comprises aground terminal opening 242, a first terminal opening 244, a secondterminal opening 246, a third terminal opening 248, a fourth terminalopening 250, and a fifth terminal opening 252. The terminal openings242, 244, 246, 248, 250, 252 of the masking element 218 are configuredto overlap and/or be aligned with respective connection parts 222A,224A, 226A, 228A, 230A, 232A of the electrodes of the electrodeassembly.

The masking element 218 has a plurality of sensor point openings. Thesensor point openings comprise primary sensor point openings shownwithin dotted line 254, each primary sensor point opening configured tooverlap a part of the ground electrode 222 and/or a part of the fourthelectrode 230. The primary sensor point openings 254 comprise, in theillustrated exemplary masking element, five primary first sensor pointopenings 254A each configured to overlap a part of the ground electrode222. The primary sensor point openings 254 comprise, in the illustratedexemplary masking element, four primary second sensor point openings254B each configured to overlap a part of the fourth electrode 230. Thesensor point openings comprise secondary sensor point openings shownwithin dotted line 256, each second sensor point opening configured tooverlap a part of the fourth electrode 230 and/or a part of the fifthelectrode 232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, five secondary first sensor pointopenings 256A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings 256 comprise, in theillustrated exemplary masking element, four secondary second sensorpoint openings 256B each configured to overlap a part of the fourthelectrode 230. The sensor point openings comprise tertiary sensor pointopenings shown within dotted line 258, each tertiary sensor openingconfigured to overlap a part of the fifth electrode 232 and/or a part ofthe ground electrode 222. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, five tertiaryfirst sensor point openings 258A each configured to overlap a part ofthe fifth electrode 232. The tertiary sensor point openings 258comprise, in the illustrated exemplary masking element, four tertiarysecond sensor point openings 258B each configured to overlap a part ofthe ground electrode 222.

FIG. 8 is a distal view of an exemplary first adhesive layer. The firstadhesive layer 200 has a plurality of sensor point openings. The sensorpoint openings of the first adhesive layer comprise primary sensor pointopenings shown within dotted line 260, each primary sensor point openingconfigured to overlap a part of the ground electrode 222 and/or a partof the fourth electrode 230 of the electrode assembly. The primarysensor point openings 260 comprise, in the illustrated exemplary firstadhesive layer, five primary first sensor point openings 260A eachconfigured to overlap a part of the ground electrode 222. The primarysensor point openings 260 comprise, in the illustrated exemplary firstadhesive layer, four primary second sensor point openings 260B eachconfigured to overlap a part of the fourth electrode 230. The sensorpoint openings of the first adhesive layer comprise secondary sensorpoint openings shown within dotted line 262, each second sensor pointopening configured to overlap a part of the fourth electrode 230 and/ora part of the fifth electrode 232 of the electrode assembly. Thesecondary sensor point openings 262 comprise, in the illustratedexemplary first adhesive layer, five secondary first sensor pointopenings 262A each configured to overlap a part of the fifth electrode232. The secondary sensor point openings 262 comprise, in theillustrated exemplary first adhesive layer, four secondary second sensorpoint openings 262B each configured to overlap a part of the fourthelectrode 230. The sensor point openings of the first adhesive layercomprise tertiary sensor point openings shown within dotted line 264,each tertiary sensor opening configured to overlap a part of the fifthelectrode 232 and/or a part of the ground electrode 222 of the electrodeassembly. The tertiary sensor point openings 264 comprise, in theillustrated exemplary first adhesive layer, five tertiary first sensorpoint openings 264A each configured to overlap a part of the fifthelectrode 232. The tertiary sensor point openings 264 comprise, in theillustrated exemplary first adhesive layer, four tertiary second sensorpoint openings 264B each configured to overlap a part of the groundelectrode 222. FIG. 9 is a proximal view of the first adhesive layer ofFIG. 8 .

FIG. 10 is a more detailed distal view of a part of the base plate 4and/or the sensor assembly part 700. The base plate 4 and/or the sensorassembly part 700 comprises a monitor interface 207. The monitorinterface 207 comprises the first connector 211. The first connector 211comprises coupling part 210 configured to releasably couple the monitordevice to the base plate 4 and/or the sensor assembly part 700 and thusforming a releasable coupling. The first connector 211 of the monitorinterface 207 comprises a plurality of terminals formed by respectiveterminal elements for forming respective electrical connections withrespective terminals of the monitor device.

The plurality of terminals of the first connector 211 of the monitorinterface 207 comprises a ground terminal element 282 forming a groundterminal 282A, a first terminal element 284 forming a first terminal284, a second terminal element 286 forming a second terminal 286A, and athird terminal element 288 forming a third terminal 288A. The monitorinterface 207 optionally comprises a fourth terminal element 290 forminga fourth terminal 290A and/or a fifth terminal element 292 forming afifth terminal 290. The terminal elements 282, 284, 286, 288, 290, 292contact respective connection parts 222A, 224A, 226A, 228A, 230 a, 232Aof electrodes 222, 224, 226, 228, 230, 232.

FIG. 11 illustrates an exploded view of an exemplary base plate 4 of anostomy appliance. The base plate 4 comprises a first adhesive layer 200.The base plate 4 optionally comprises a second adhesive layer 202, alsodenoted rim adhesive layer. The base plate 4 comprises a plurality ofelectrodes 216 arranged in an electrode assembly 204. The electrodeassembly 204 is arranged between the first adhesive layer 200 and thesecond adhesive layer 202. The electrode assembly 204 optionallycomprises a support layer 214. The electrodes may be formed on aproximal side of the support layer 214, such as by printing ofconductive ink. The electrode assembly 204 optionally comprises amasking element 218, e.g. covering or overlapping with parts of theelectrodes 216 when seen in the axial direction, e.g. from a proximalside of the electrodes 216. The electrode assembly has a first part 302comprising connection parts 217 of the plurality of electrodes 216. Theelectrode assembly has a second part 303. The base plate 4 comprises arelease liner 206. The base plate 4 comprises a top layer 208. The baseplate 4 optionally comprises a coupling ring 209 for coupling an ostomypouch to the base plate 4. Alternatively, e.g. for a one-part ostomyappliance, a ostomy pouch may be directly fastened to the base plate 4.

The base plate 4 comprises a monitor interface configured forconnecting, such as mechanically and/or electronically connecting, thebase plate to a monitor device. The monitor interface comprises aplurality of terminals 212 configured to form electrical connectionswith respective terminals of the monitor device. For example, asillustrated, the connection parts 217 may form the plurality ofterminals 212 of the monitor interface. Alternatively, e.g. as shown inFIG. 3 , terminal elements may be provided to form the plurality ofterminals.

The top layer 208 comprises a top layer opening 304. The second adhesivelayer 202 comprises a second adhesive layer opening 306. The top layeropening 304 and the second adhesive layer opening 306 are configured toallow for connection between the plurality of electrodes 216 of theelectrode assembly 204 and terminals of a monitor device being coupledto the base plate 4. For example, the first part 302 of the electrodeassembly 216 may extend through the top layer opening 304 and the secondadhesive layer opening 306.

As described in respect to FIG. 3 , some parts of the illustrated baseplate 4, may be provided as a separate assembly to be applied to anexisting base plate, e.g. comprising one or more of the components asdescribed, such as to provide a base plate like the base plate 4 asdescribed. For example, a sensor assembly part 700 may be provided, e.g.comprising the electrode assembly 204, the first adhesive layer 200 andthe release liner 206. Additionally, the sensor assembly part 700 mayalso comprise the second adhesive layer 202 and/or the top layer 208. Itmay be envisioned that the user may provide a hole in layers of the baseplate whereto the sensor assembly part 700 is to be applied, to allowfor connection between the plurality of electrodes 216 of the electrodeassembly 204 and terminals of a monitor device being coupled to the baseplate 4.

FIG. 12 illustrates an exploded view of an exemplary electrode assembly204 of a base plate and/or a sensor assembly part, such as the baseplate 4 or sensor assembly part 700 of FIG. 11 . The electrode assembly204 has a distal side 204A and a proximal side 204B. The electrodeassembly comprises a support layer 214 with a proximal side 214B and adistal side 214A. The electrode assembly 204 comprises a plurality ofelectrodes 216. Each electrode of the plurality of electrodes 216 has arespective connection part 217 for connecting the electrodes 216 torespective terminal elements of the monitor interface. The electrodes216 are provided, such as formed, on the proximal side 214B of thesupport layer 214, e.g. the electrodes 216 may be positioned on theproximal side 214B of the support layer 214. Further, electrode assembly204 optionally comprises a masking element 218 with proximal side 218Band configured to insulate electrode parts of electrodes 216 from thefirst adhesive layer 200 of the base plate 4 and/or the sensor assemblypart 700 (see FIG. 11 ). The masking element 218 covers or overlap withparts of the electrodes 216 when seen in the axial direction, e.g. fromthe proximal side 204B. The masking element 218 may be configured not tocover or overlap the connecting parts 217 of the plurality ofelectrodes.

In some exemplary electrode assembly 204, such as the electrode assembly204 of FIG. 12 , the electrode assembly 204 comprises a reinforcementelement 308. The reinforcement element 308 may be positioned proximal tothe electrode assembly 216, such as proximal to the plurality ofelectrodes 216, such as proximal to the plurality of connection parts217 of the plurality of electrodes 216. The reinforcement element 308may form at least part of a first part of the electrode assembly 204.The reinforcement element 308 may be provided with openings 310 toprovide conductive pathways between sides of the reinforcement element308, such as between a proximal side 308B and a distal side 308A of thereinforcement element 308.

FIG. 13 shows an alternative to FIG. 12 , wherein the reinforcementelement 308 comprises a plurality of conductive paths 311. For example,the reinforcement element 308 may be a flex circuit. The plurality ofconductive paths 311 may be connected to the plurality of electrodes216. The plurality of conducive paths 311 thereby may form theconnection parts 217 of the plurality of electrodes 216. The pluralityof conductive paths 311 may provide conductive pathways between theproximal side 308B and the distal side 308A of the reinforcement element308.

FIG. 14 shows an exemplary electrode configuration 220 of the pluralityof electrodes 216, like the electrode configuration 220 as shown in FIG.6 , with the difference that the connection parts 217, such as theground connection part 222A, the first connection part 224A, the secondconnection part 226A, the third connection part 228A, the fourthconnection part 230A and/or the fifth connection part 232A, are straightconnector parts.

FIG. 15 , shows a sectional schematic representation of part of a baseplate 4 and/or a sensor assembly part 700. The base plate 4 and/or thesensor assembly part 700 comprises a first adhesive layer 200, anoptional second adhesive layer 202, and a top layer 208. An electrodeassembly comprising a plurality of electrodes 216 is arranged betweenthe first adhesive layer 200 and the top layer 208, such as between thefirst adhesive layer 200 and the second adhesive layer 202. For example,a second part of the electrode assembly is arranged between the firstadhesive layer and the second adhesive layer 202 and/or the top layer208. The electrode assembly further comprises an optional reinforcementelement 308.

The top layer 208 and the second adhesive layer 202 comprise openings304; 306. The top layer 208 comprises a top layer opening 304. Thesecond adhesive layer 202 comprises a second adhesive layer opening 306.A first part 302 of the electrode assembly extends through the top layeropening 304 and the second adhesive layer opening 306. The first part302 includes the connection parts of the plurality of electrodes and thereinforcement element 308. The first part 302 may include the supportlayer 214 or a part of the support layer. Connection to the connectionparts 217 of the plurality of electrodes may be provided through thereinforcement element 308 and/or through the support layer 214.

FIG. 16 , shows a sectional schematic representation of part of a baseplate 4 and/or a sensor assembly part 700 as shown in FIG. 15 , whereinthe base plate 4 and/or the sensor assembly part 700 comprises acoupling part 210. The coupling part 210 is configured for forming amechanical connection between the monitor device and the base plate 4and/or the sensor assembly part 700. The first part 302 of the electrodeassembly is extending into the coupling part 210, e.g. to allow themonitor device, such as terminals of the monitor device to connect tothe electrodes 216 of the base plate 4 and/or the sensor assembly part700.

In the example shown, the coupling part 210 is attached to the top layer208. However, in an alternative example, the coupling part 210 isattached to the electrode assembly, in such situation the coupling part210 may extend through the top layer opening 304 and the second adhesivelayer opening 306.

FIG. 17 , shows a sectional schematic representation of part of a baseplate 4 and/or a sensor assembly part 700. The base plate 4 and/or thesensor assembly part 700 comprises a first adhesive layer 200, anoptional second adhesive layer 202, and a top layer 208. An electrodeassembly comprising a plurality of electrodes 216 is arranged betweenthe first adhesive layer 200 and the top layer 208, such as between thefirst adhesive layer 200 and the second adhesive layer 202. For example,a second part of the electrode assembly is arranged between the firstadhesive layer and the second adhesive layer 202 and/or the top layer208.

The top layer 208 comprises a top layer opening 304. The second adhesivelayer 202 comprises a second adhesive layer opening 306. The top layeropening 304 and the second adhesive layer opening 306 is provided by aU-shaped cut. A first part 302 of the electrode assembly is turned over,together with a part of the top layer 208 and the second adhesive layer202 inside the U-shaped cut, to expose the connection parts 217 of theplurality of electrodes 216 on a distal side of the base plate 4 and/orthe sensor assembly part 700. The first part 302 includes the connectionparts 217 of the plurality of electrodes and extends through the toplayer opening 304 and the second adhesive layer opening 306. The monitordevice may thereby connect to the plurality of connection parts 217.Although not shown in FIG. 17 , the electrode assembly may furthercomprise an optional reinforcement element 308, e.g. as illustrated inFIGS. 15 and 16 and/or the base plate 4 and/or the sensor assembly part700 may be provided with a coupling part 210, e.g. as shown in FIG. 16 .

The base plate 4 and/or the sensor assembly part 700 comprises a backelement 312. The back element 312 is provided between the first adhesivelayer 200 and the electrode assembly and/or the plurality of electrodes216 of the electrode assembly, such as between the first adhesive layer200 and the first part 302 of the electrode assembly. The back element312 may facilitate that the first part 302 of the electrode assembly isnot adhering to the first adhesive layer, such as to allow the firstpart 302 of the electrode assembly to be turned. A back element 312 maysimilarly be applied to the exemplary base plates and/or sensor assemblyparts as described in relation to FIGS. 15 and/or 16 .

FIG. 18 shows a flowchart of an exemplary method 1000, such as a methodfor manufacturing a base plate or a sensor assembly part for an ostomyappliance. The method comprises providing 1002 a top layer, optionallyproviding 1004 a second adhesive layer, and providing 1006 an electrodeassembly comprising a plurality of electrodes, the electrode assemblyhaving a first part and a second part, the first part comprisingconnection parts of the plurality of electrodes. The method furthercomprises: providing 1008 a first adhesive layer, assembling 1010 thetop layer, the optional second adhesive layer, the electrode assemblyand the first adhesive layer, and providing 1012 a top layer opening inthe top layer and optionally a second adhesive layer opening in thesecond adhesive layer.

Assembling 1010 the top layer, the optional second adhesive layer, theelectrode assembly and the first adhesive layer includes assembling suchthat the electrode assembly is arranged between the first adhesive layerand the top layer and/or between the first adhesive layer and theoptional second adhesive layer. For example, assembling 1010 the toplayer, the optional second adhesive layer, the electrode assembly andthe first adhesive layer includes assembling such that the second partof the electrode assembly, e.g. comprising sensing parts of theplurality of electrodes, is arranged between the first adhesive layerand the second adhesive layer/the top layer.

Providing 1012 the top layer opening and the optional second adhesivelayer opening comprises providing 1012 the top layer opening and theoptional second adhesive layer opening, such that the top layer openingand the optional second adhesive layer opening is configured to allowfor connection between the plurality of electrodes of the electrodeassembly and terminals of the monitor device.

The method 1000 furthermore optionally comprises directing 1014 thefirst part of the electrode assembly through the top layer opening andthe optional second adhesive layer opening. Directing 1014 the firstpart of the electrode assembly through the top layer opening and theoptional second adhesive layer may include turning over the first partof the electrode assembly, such as to expose the connection parts of theplurality of electrodes on a distal side of the base plate and/or thesensor assembly part.

The method 1000 furthermore optionally comprises providing 1016 acoupling part on the base plate and/or the sensor assembly part. Thecoupling part may be provided 1016 to be aligned with the top layeropening and the optional second adhesive layer opening. The couplingpart may be provided 1016 to be aligned with the first part of theelectrode assembly.

As illustrated, the top layer opening and the optional second adhesivelayer opening may be provided 1010 after assembling 1008. Alternatively,the top layer opening and the optional second adhesive layer opening maybe provided 1010 before assembling 1008.

For example, the top layer opening and the optional second adhesivelayer opening may be provided before providing the electrode assembly.The top layer opening and the optional second adhesive layer opening maybe provided simultaneously, e.g. by cutting through both the top layerand the second adhesive layer.

The position of the first connector on the base plate and/or the sensorassembly part, the number of terminals and the position of the terminalsin the coupling part may be adapted to the electrode configuration usedin the electrode assembly of the base plate and/or the sensor assemblypart.

The use of the terms “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. does not imply any particular order but isincluded to identify individual elements. Moreover, the use of the terms“first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. does not denote any order or importance, but rather theterms “first”, “second”, “third” and “fourth”, “primary”, “secondary”,“tertiary” etc. are used to distinguish one element from another. Notethat the words “first”, “second”, “third” and “fourth”, “primary”,“secondary”, “tertiary” etc. are used here and elsewhere for labellingpurposes only and are not intended to denote any specific spatial ortemporal ordering. Furthermore, the labelling of a first element doesnot imply the presence of a second element and vice versa.

Although particular features have been shown and described, it will beunderstood that they are not intended to limit the claimed invention,and it will be made obvious to those skilled in the art that variouschanges and modifications may be made without departing from the spiritand scope of the claimed invention. The specification and drawings are,accordingly to be regarded in an illustrative rather than restrictivesense. The claimed invention is intended to cover all alternatives,modifications and equivalents.

Exemplary embodiments of the present disclosure are set out in thefollowing items:

-   -   1. A base plate for an ostomy appliance, the base plate        comprising:        -   a top layer;        -   a first adhesive layer; and        -   an electrode assembly comprising a plurality of electrodes,            the electrode assembly having a first part and a second            part, the first part comprising connection parts of the            plurality of electrodes, the second part being arranged            between the first adhesive layer and the top layer;        -   a monitor interface configured for connecting the base plate            to a monitor device, the monitor interface comprising a            plurality of terminals configured to form electrical            connections with respective terminals of the monitor device,            wherein the top layer comprises a top layer opening            configured to allow for connection between the plurality of            electrodes of the electrode assembly and terminals of the            monitor device.    -   2. The base plate of item 1, wherein the connection parts form        the plurality of terminals of the monitor interface.    -   3. The base plate of any of items 1 or 2, wherein the first part        of the electrode assembly extends through the top layer opening.    -   4. The base plate of item 3, wherein the electrode assembly        comprises a proximal side and a distal side, and wherein the        plurality of electrodes is arranged on the proximal side, and        wherein the first part of the electrode assembly is turned over        to expose the connection parts of the plurality of electrodes on        a distal side of the base plate.    -   5. The base plate of any of items 1-3, wherein the electrode        assembly comprises a proximal side and a distal side, and        wherein the plurality of electrodes is arranged on the proximal        side, and wherein the connection parts of each of the plurality        of electrodes extend from the proximal side of the electrode        assembly to the distal side of the electrode assembly, such as        through a support layer of the electrode assembly.    -   6. The base plate of any of the preceding items, wherein the top        layer opening is U-shaped.    -   7. The base plate of any of the preceding items, wherein the        monitor interface comprises a coupling part configured for        forming a mechanical connection, such as a releasable coupling,        between the monitor device and the base plate.    -   8. The base plate of item 7, wherein the coupling part is        attached to the electrode assembly, such as the distal side of        the electrode assembly, and wherein the coupling part extends        through the top layer opening.    -   9. The base plate of item 7, wherein the coupling part is        attached to the top layer, such as the distal side of the top        layer.    -   10. The base plate of any of items 7-9, wherein the first part        of the electrode assembly is extending into the coupling part.    -   11. The base plate of any of the preceding items, wherein the        electrode assembly comprises a reinforcement element, and        wherein the reinforcement element is forming at least part of        the first part of the electrode assembly.    -   12. The base plate of item 11, wherein the reinforcement element        comprises a plurality of conductive paths connected to the        plurality of electrodes to form the connection parts of the        plurality of electrodes.    -   13. The base plate of any of items 11 or 12, wherein the        reinforcement element is a flex circuit.    -   14. The base plate of any of the preceding items comprising a        second adhesive layer between the top layer and the electrode        assembly, and wherein the second adhesive layer comprises a        second adhesive layer opening aligned with the top layer opening        and configured to allow for electrical connection between the        plurality of electrodes of the electrode assembly and terminals        of the monitor device.    -   15. Method for manufacturing a base plate or a sensor assembly        part for an ostomy appliance, the method comprising:        -   providing a top layer;        -   providing an electrode assembly comprising a plurality of            electrodes, the electrode assembly having a first part and a            second part, the first part comprising connection parts of            the plurality of electrodes;        -   providing a first adhesive layer; and        -   assembling the top layer, the electrode assembly and the            first adhesive layer, such that the second part of the            electrode assembly is arranged between the first adhesive            layer and the top layer,    -   the method further comprising:        -   providing a top layer opening in the top layer, the top            layer opening being configured to allow for connection            between the plurality of electrodes of the electrode            assembly and terminals of the monitor device.    -   16. Method according to item 15 wherein the top layer opening is        provided in the top layer after assembling the top layer, the        electrode assembly and the first adhesive layer.    -   17. Method according to item 15 wherein the top layer opening is        provided in the top layer before assembling the top layer, the        electrode assembly and the first adhesive layer.    -   18. Method according to any of items 15-17, wherein the top        layer opening is provided by cutting a U-shaped cut in the top        layer.    -   19. A sensor assembly part for an ostomy appliance, the sensor        assembly part comprising:        -   a top layer;        -   a first adhesive layer; and        -   an electrode assembly comprising a plurality of electrodes,            the electrode assembly having a first part and a second            part, the first part comprising connection parts of the            plurality of electrodes, the second part being arranged            between the first adhesive layer and the top layer;        -   a monitor interface configured for connecting the sensor            assembly part to a monitor device, the monitor interface            comprising a plurality of terminals configured to form            electrical connections with respective terminals of the            monitor device,    -   wherein the top layer comprises a top layer opening configured        to allow for connection between the plurality of electrodes of        the electrode assembly and terminals of the monitor device.    -   20. The sensor assembly part of item 19, wherein the connection        parts form the plurality of terminals of the monitor interface.    -   21. The sensor assembly part of any of items 19 or 20, wherein        the first part of the electrode assembly extends through the top        layer opening.    -   22. The sensor assembly part of item 21, wherein the electrode        assembly comprises a proximal side and a distal side, and        wherein the plurality of electrodes is arranged on the proximal        side, and wherein the first part of the electrode assembly is        turned over to expose the connection parts of the plurality of        electrodes on a distal side of the sensor assembly part.    -   23. The sensor assembly part of any of items 19-21, wherein the        electrode assembly comprises a proximal side and a distal side,        and wherein the plurality of electrodes is arranged on the        proximal side, and wherein the connection parts of each of the        plurality of electrodes extend from the proximal side of the        electrode assembly to the distal side of the electrode assembly,        such as through a support layer of the electrode assembly.    -   24. The sensor assembly part of any of items 19-23, wherein the        top layer opening is U-shaped.    -   25. The sensor assembly part of any of items 19-24, wherein the        monitor interface comprises a coupling part configured for        forming a mechanical connection, such as a releasable coupling,        between the monitor device and the sensor assembly part.    -   26. The sensor assembly part of item 25, wherein the coupling        part is attached to the electrode assembly, such as the distal        side of the electrode assembly, and wherein the coupling part        extends through the top layer opening.    -   27. The sensor assembly part of item 25, wherein the coupling        part is attached to the top layer, such as the distal side of        the top layer.    -   28. The sensor assembly part of any of items 25-27, wherein the        first part of the electrode assembly is extending into the        coupling part.    -   29. The sensor assembly part of any of items 19-28, wherein the        electrode assembly comprises a reinforcement element, and        wherein the reinforcement element is forming at least part of        the first part of the electrode assembly.    -   30. The sensor assembly part of item 29, wherein the        reinforcement element comprises a plurality of conductive paths        connected to the plurality of electrodes to form the connection        parts of the plurality of electrodes.    -   31. The sensor assembly part of any of items 29 or 30, wherein        the reinforcement element is a flex circuit.    -   32. The sensor assembly part of any of items 19-31 comprising a        second adhesive layer between the top layer and the electrode        assembly, and wherein the second adhesive layer comprises a        second adhesive layer opening aligned with the top layer opening        and configured to allow for electrical connection between the        plurality of electrodes of the electrode assembly and terminals        of the monitor device.

LIST OF REFERENCES

-   -   1 ostomy system    -   2 ostomy appliance    -   4 base plate    -   6 monitor device    -   8 accessory device    -   10 server device    -   12 network    -   14 coupling member    -   16 coupling ring    -   18 stoma-receiving opening    -   100 monitor device housing    -   101 processor    -   102 first interface    -   104 second interface    -   106 memory    -   108 ground terminal of monitor device    -   110 first terminal of monitor device    -   112 second terminal of monitor device    -   114 third terminal of monitor device    -   116 fourth terminal of monitor device    -   118 fifth terminal of monitor device    -   120 coupling part    -   122 antenna    -   124 wireless transceiver    -   126 loudspeaker    -   128 haptic feedback element    -   200 first adhesive layer    -   200A distal side/surface of first adhesive layer    -   200B proximal side/surface of first adhesive layer    -   202 second adhesive layer    -   202A distal side/surface of second adhesive layer    -   202B proximal side/surface of second adhesive layer    -   204 electrode assembly    -   204A distal side/surface of electrode assembly    -   204B proximal side/surface of electrode assembly    -   206 release liner    -   206A distal side/surface of the release liner    -   206B proximal side/surface of the release liner    -   207 monitor interface    -   208 top layer    -   208A distal side/surface of the top layer    -   208B proximal side/surface of the top layer    -   209 coupling ring    -   210 coupling part of first connector    -   211 first connector    -   212 terminals of first connector    -   213 first intermediate element    -   213A distal side/surface of first intermediate element    -   213B proximal side/surface of first intermediate element    -   214 support layer of electrode assembly    -   214A distal side/surface of support layer    -   214B proximal side/surface of support layer    -   216 electrodes of electrode assembly    -   217 connection parts    -   218 masking element    -   218A distal side/surface of masking element    -   218B proximal side/surface of masking element    -   220 electrode configuration    -   222 ground electrode    -   222A ground connection part    -   222B ground sensing part    -   224 first electrode    -   224A first connection part    -   226 second electrode    -   226A second connection part    -   228 third electrode    -   228A third connection part    -   230 fourth electrode    -   230A fourth connection part    -   230B fourth sensing part    -   232 fifth electrode    -   232A fifth connection part    -   232B fifth sensing part    -   234 first electrode part of the ground electrode    -   236 second electrode part of the ground electrode    -   238 third electrode part of the ground electrode    -   240 fourth electrode part of the ground electrode    -   242 ground terminal opening    -   244 first terminal opening    -   246 second terminal opening    -   248 third terminal opening    -   250 fourth terminal opening    -   252 fifth terminal opening    -   254 primary sensor point openings of masking element    -   254A primary first sensor point opening    -   254B primary second sensor point opening    -   256 secondary sensor point openings of masking element    -   256A secondary first sensor point opening    -   256B secondary second sensor point opening    -   258 tertiary sensor point openings of masking element    -   258A tertiary first sensor point opening    -   258B tertiary second sensor point opening    -   260 primary sensor point openings of first adhesive layer    -   260A primary first sensor point opening    -   260B primary second sensor point opening    -   262 secondary sensor point openings of first adhesive layer    -   262A secondary first sensor point opening    -   262B secondary second sensor point opening    -   264 tertiary sensor point openings of first adhesive layer    -   264A tertiary first sensor point opening    -   264B tertiary second sensor point opening    -   270 terminal interface region    -   272 terminal element(s)    -   272A distal end of terminal element(s)    -   272B proximal end of terminal element(s)    -   274A distal part of terminal element(s)    -   274B proximal part of terminal element(s)    -   276A distal terminal element bend    -   276B proximal terminal element bend    -   278 guide hole    -   282 ground terminal element    -   282A ground terminal    -   284 first terminal element    -   284A first terminal    -   286 second terminal element    -   286A second terminal    -   288 third terminal element    -   288A third terminal    -   290 fourth terminal element    -   290A fourth terminal    -   292 fifth terminal element    -   292A fifth terminal    -   302 first part of electrode assembly    -   303 second part of electrode assembly    -   304 top layer opening    -   306 second adhesive layer opening    -   308 reinforcement element    -   308A distal side of reinforcement element    -   308B proximal side of reinforcement element    -   310 openings    -   311 conductive paths    -   312 back element    -   700 sensor assembly part    -   1000 method    -   1002 providing top layer    -   1004 providing second adhesive layer    -   1006 providing electrode assembly    -   1008 providing first adhesive layer    -   1010 assembling layers    -   1012 providing layer opening(s)    -   1014 directing part of electrode assembly    -   1016 providing coupling part    -   M number of terminals in the first interface of the monitor        device

1. An ostomy base plate comprising: an adhesive layer on a proximalsurface of the ostomy base plate, where the adhesive layer is adapted toadhere the ostomy base plate to skin of a user; a top layer on a distalside of the ostomy base plate, the top layer provided with a top layeropening; and a sensor assembly disposed between the adhesive layer andthe top layer, the sensor assembly including a plurality of electrodeswith electrical connection parts; wherein the electrical connectionparts of the plurality of electrodes of the sensor assembly extendthrough the top layer opening in the top layer for electrical connectionwith a removable data monitor; wherein the sensor assembly is adapted tocommunicate to the removable data monitor information related to a stateof condition of the adhesive layer.
 2. The ostomy base plate of claim 1,wherein the sensor assembly is adapted to communicate to the removabledata monitor information related to erosion of the adhesive layer. 3.The ostomy base plate of claim 1, wherein the sensor assembly is adaptedto communicate to the removable data monitor information related toleakage of stomal output relative to the adhesive layer.
 4. The ostomybase plate of claim 1, wherein the sensor assembly is adapted tocommunicate to the removable data monitor information related to aclassification of stomal output leakage conditions relative to theadhesive layer.
 5. The ostomy base plate of claim 1, wherein theadhesive layer comprises one of a water soluble hydrocolloid and a waterswellable hydrocolloid.
 6. The ostomy base plate of claim 1, furthercomprising: a support layer; wherein the plurality of electrodes isdisposed on a proximal side of the support layer, with the plurality ofelectrodes on a distal side of the adhesive layer.
 7. The ostomy baseplate of claim 1, further comprising: a reinforcement layer; wherein thereinforcement layer is disposed on a proximal side of the sensorassembly, with the reinforcement layer extending through the top layeropening in the top layer.
 8. The ostomy base plate of claim 1, furthercomprising: a support layer, with the plurality of electrodes disposedon a proximal side of the support layer; and a reinforcement layer, withthe reinforcement layer disposed on a proximal side of the sensorassembly and the support layer; wherein the reinforcement layer extendsthrough the top layer opening in the top layer to provide a reinforcedmonitor interface for electrical connection between electricalconnection parts of the plurality of electrodes of the sensor assemblyand the removable data monitor.
 9. The ostomy base plate of claim 8,wherein the plurality of electrodes is printed on the proximal side ofthe support layer.
 10. The ostomy base plate of claim 8, wherein thereinforced monitor interface further comprises a coupling partconfigured for forming a mechanical connection with the removable datamonitor.
 11. The ostomy base plate of claim 8, wherein the reinforcementlayer comprises a plurality of conductive paths connected to theplurality of electrodes to form the electrical connection parts of theplurality of electrodes.
 12. The ostomy base plate of claim 8, whereinthe reinforcement layer comprises a flex circuit.
 13. The ostomy baseplate of claim 1, further comprising: a second adhesive layer disposedbetween the top layer and the sensor assembly; wherein the secondadhesive layer comprises a second adhesive layer opening aligned withthe top layer opening.
 14. The ostomy base plate of claim 13, whereinthe second adhesive layer comprises one of a water soluble hydrocolloidand a water swellable hydrocolloid.
 15. An ostomy base plate comprising:an adhesive layer on a proximal surface of the ostomy base plate, wherethe adhesive layer is adapted to adhere the ostomy base plate to skin ofa user; a top layer on a distal side of the ostomy base plate, the toplayer provided with a top layer opening; and a sensor assembly disposedbetween the adhesive layer and the top layer, the sensor assemblyincluding a plurality of electrodes with electrical connection parts;wherein the electrical connection parts of the plurality of electrodesof the sensor assembly extend through the top layer opening in the toplayer for electrical connection with a removable data monitor; whereinthe sensor assembly is adapted to monitor a state of condition of theadhesive layer.